Amylin waging legal war with Lilly over blockbuster Boehringer pact

When Eli Lilly and Boehringer Ingelheim announced early this year that they would join forces to advance new treatments to fight diabetes, the news evidently stirred considerable passion at Amylin, which has been struggling alongside Lilly to push Bydureon to an approval at the FDA. Today Amylin went public with its objections, filing suit claiming that the ambitious deal violated its own long-standing partnership with the pharma giant on the blockbuster Byetta.

Amylin's primary objection is focused on Boehringer's program for linagliptin, which Amylin sees as a big threat to Byetta. Bydureon--widely tapped as a likely blockbuster--is designed as the next-gen follow-up diabetes treatment to Byetta, and both rely on exenatide as the active ingredient. Amylin's suit seeks to stop Lilly from using the same sales force to promote linagliptin as the one now dedicated to Byetta. But at the same time Amylin wants to continue to develop new products with Lilly.

"Amylin selected Lilly as a partner to promote development and maximize sales of Amylin's exenatide products," says the company. "We are disappointed that we could not resolve this matter amicably and that we were forced to bring legal action to protect our rights, our products and our shareholders. Amylin is committed to exenatide, a franchise that we believe provides important treatment options for the millions of patients around the world with type 2 diabetes. Notwithstanding this litigation, we intend to continue to collaborate with Lilly in the development and commercialization of exenatide products."

Lilly wasted little time this morning in firing back its response to its longtime partner. "We believe the lawsuit is without merit and will vigorously defend our position," said Enrique Conterno, president of Lilly Diabetes, in a statement. "Our mission as a company is to bring needed therapeutic solutions to patients. Significant unmet need exists among patients with diabetes, and the condition's prevalence and complications from it are projected to rise sharply as we look to the future. Lilly has a strong heritage of bringing new diabetes innovations to the market and we know that patients and health care professionals want choices to treat this complex disease throughout its progression."

The deal between Lilly and Boehringer matched two powerhouses actively developing new treatments for diabetes. Lilly agreed to make an initial one-time payment to Boehringer Ingelheim of €300 million, adding €625 million in success-based regulatory milestones for linagliptin and BI10773. Lilly became eligible to receive up to $650 million in regulatory milestones on its two basal analogue insulins. And if Boehringer opted in to the Phase III development and potential commercialization of the antibody, Lilly would be eligible for up to $525 million in opt-in and success-based regulatory milestone payments. The companies agreed to share ongoing development costs equally.